| 08:00 |
Registration and Refreshments |
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| 08:55 |
Opening Remarks by the Chairman
Prof. Gernod Dittel
CEO, Dittel Engineering |
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| SESSION 3: SECTOR FOCUS-CLEAN LIFE SCIENCES |
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| 09:00 |
Cleanrooms Design and Construction: Stages and Typical Mistakes |
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• Key stages in design and construction
• Delivery of project from start to turnkey
• Cleanroom management in pharmaceuticals and healthcare
Hitesh Upreti
MD, Zenufa
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| 09:30 |
Cleanroom Garments from a Quality Risk Management Perspective |
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• Understanding “people in cleanroom”
• Reviewing and resolving the major contamination factors
• Staff gowning and personnel behavior
Matts Ramstorp
BioTekPro, Sweden
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| 10:00 |
ePTFE and eFRM membrane HEPA/ULPA filters for pharmaceutical and microelectronics application |
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• ePTFE and eFRM membrane HEPA/ULPA filters, structure and media properties vs glass media
• validation of ePTFE and eFRM membrane HEPA/ULPA filters
• risk reduction, energy savings
• benefits of ePTFE and eFRM membrane HEPA/ULPA filters
Dr. Marc Schmidt
Director Research and Development – Europe, AAF International |
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| 10:30 |
Coffee and Networking |
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| 11:00 |
GMP Annex 1: A new Dawn in Garment Selection |
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• Understanding the impact of GMP Annex 1 on contamination control strategies
• Different garment systems and results of the DuPont study on reusable garments
• Value chain assessment
Jean-Francois Teneul
Global Life Sciences Market Leader – Personal Protection, DuPont de Nemours |
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| 11:30 |
Sterile Compounding Program Elements: Quality Control and Best Practice |
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Provides the necessary information and guidance, to assure the production of high-quality, compounded sterile preparations:
• Employee Education
• Compounding Process
• Quality Assurance
Dr. Nura Al Banyan
Lead Pharmacist, King Fahd Medical Centre
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| 12:00 |
Lab Cleanliness Assessment for Infection Prevention and Control |
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• Check on microbial contaminants
• Limitations of sampling equipment
• Sterility assurance in environment monitoring
Dr. Najiba Abdul Razzaq
Head of Infection Control, Ministry of Health, UAE |
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| 12:20 |
Interactive Panel Discussion |
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| 13:00 |
Prayer and Lunch Break |
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| 14:00 |
Containment Room Applications |
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• Sealing requirements in clean and contained Rooms
• Classic methods of sealing cable and pipe entries and the cost of failure
• Optimized cable and pipe sealing methods
• Case study
• Need for specifications on effective sealing methods
Mohammed Toubasi
Technical Manager, Roxtec
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| 14:30 |
Is the IVF Industry Ready for Cleanroom Technology? |
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The talk will outline the special considerations that are paramount within a laboratory for successful embryo culture and high pregnancy rates with emphasis on laboratory environment and air quality. The current international standards and guidelines will be discussed and the need for the implementation of cleanroom technologies in the sector.
• The IVF laboratory and its processes
• Air quality and the challenges of In Vitro Embryo culture
• Current standards and guidelines
• Future trends and developments
Giles Palmer
Business and Quality Manager, London Women's Clinic
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| 15:00 |
Microbiology in Cleanrooms and Isolators used for Sterility Testing |
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• Regulatory Requirements
• State of the art Sterility Testing
• Qualification of Isolators
• Microbiological Monitoring
• Comparison Isolator vs. Cleanroom
Dr. Timo Krebsbach
Managing Director, HHAC Laboratory Heusler GmbH |
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| 16:00 |
Closing Remarks and End of Cleanzone Middle East 2019 |